Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.
Primary Purpose
Class V Dental Caries
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Giomer based injectable resin composite
Resin modified glass ionomer
Sponsored by
About this trial
This is an interventional treatment trial for Class V Dental Caries focused on measuring Giomer, injectable resin composite, Resin modified glass ionomer
Eligibility Criteria
Participant Inclusion Criteria
- Age 18-60 years.
- Co-operative patients approving to participate in the study.
- Male or female patients.
- Patients with good general health
- Moderate or high caries risk patient
Teeth Inclusion Criteria
- Cervical Class V carious lesions.
- Pulp asymptomatic vital carious teeth.
Participant Exclusion Criteria
- Systemic disease or severe medical complications.
- Participants with a history of allergy to any component of restorations will be used in the study.
- Lack of compliance
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
Teeth Exclusion Criteria
- Presence of apical or periapical pathosis.
- tooth mobility
- Non-vital teeth.
- Teeth with advanced periodontal diseases.
- Teeth which need indirect restoration.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Giomer based injectable resin composite
Resin modified glass ionomer
Arm Description
Beautifil Flow plus X F03, SHOFU, USA
Fuji II LC, GC
Outcomes
Primary Outcome Measures
Clinical performance (Marginal adaptation)
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie is the worse outcome .
Secondary Outcome Measures
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie worse outcome .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389163
Brief Title
Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.
Official Title
Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.
Detailed Description
In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class V Dental Caries
Keywords
Giomer, injectable resin composite, Resin modified glass ionomer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Giomer based injectable resin composite
Arm Type
Experimental
Arm Description
Beautifil Flow plus X F03, SHOFU, USA
Arm Title
Resin modified glass ionomer
Arm Type
Active Comparator
Arm Description
Fuji II LC, GC
Intervention Type
Device
Intervention Name(s)
Giomer based injectable resin composite
Intervention Description
Giomer material has been introduced as the true hybridization of glass ionomer and resin composite, containing surface pre-reacted glass ionomer (S-PRG) filler particles within a resin matrix. Giomer combines caries protection through fluoride release and recharge of glass ionomers and the esthetics, physical and handling properties of resin composite
Intervention Type
Device
Intervention Name(s)
Resin modified glass ionomer
Intervention Description
Resin modified glass ionomer (RMGI) have been developed to combine the advantages of both resin composite and glass ionomer; the good mechanical properties, esthetic of resin composite added to anticariogenic activity and chemical bonding to tooth structure of glass Ionomer.
Primary Outcome Measure Information:
Title
Clinical performance (Marginal adaptation)
Description
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie is the worse outcome .
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)
Description
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie worse outcome .
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participant Inclusion Criteria
Age 18-60 years.
Co-operative patients approving to participate in the study.
Male or female patients.
Patients with good general health
Moderate or high caries risk patient
Teeth Inclusion Criteria
Cervical Class V carious lesions.
Pulp asymptomatic vital carious teeth.
Participant Exclusion Criteria
Systemic disease or severe medical complications.
Participants with a history of allergy to any component of restorations will be used in the study.
Lack of compliance
Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
Teeth Exclusion Criteria
Presence of apical or periapical pathosis.
tooth mobility
Non-vital teeth.
Teeth with advanced periodontal diseases.
Teeth which need indirect restoration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Adel Hendam, Master degree
Phone
01224784965
Ext
02
Email
reham.hendam@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo university
Phone
23634965
Ext
+202
Email
dentmail@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Expecting to have all the data by October 2024
Learn more about this trial
Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.
We'll reach out to this number within 24 hrs